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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of test chemical in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
EC Number:
229-313-2
EC Name:
3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
Cas Number:
6471-49-4
Molecular formula:
C24H17N5O7
IUPAC Name:
3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide
Test material form:
solid: particulate/powder
Details on test material:
IUPAC Name: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamid
Common Name: Pigment Red 23
InChI:1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
Smiles: c12c(c(c(cc1cccc2)C(=O)Nc1cc(ccc1) [N+](=O)[O-])O)/N=N/c1c(ccc(c1)[N+](=O)[O-])OC
Name of test material (as cited in study report):TK-11451
Molecular formula:C24H17N5O7
Molecular weight: 213.2349 g/mol
Substance type:Organic
Physical State: Solid

Test animals

Species:
rat
Strain:
other: Tif. RAI rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: Animals were weighed 160 to 180 g
- Fasting period before study: The rats were starved during one night before starting the treatment.
- Housing: The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5.
- Diet (e.g. ad libitum): food, ad libitum.
- Water (e.g. ad libitum): water, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1° C
- Humidity (%): approximately 50 %

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 and 60 %
DOSAGE PREPARATION (if unusual): Test material was suspended at 50 and 60 % with carboxymethylcellulose 2 % and administered by oral intubation.
Doses:
6000 and 10000 mg/kg
No. of animals per sex per dose:
Total = 20 (sex/dose)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Mortality and general symptoms was observed at 1 h, 24 h, 48 h, and 7 days.
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for clinical signs.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed.
Mortality:
No mortality was observed at 10000 mg/kg bw.
Clinical signs:
Within 2 hours after treatment the rats of both dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. The animals had recovered within 4 to 6 days.
Body weight:
not specified
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
not specified

Any other information on results incl. tables

Table – Results

Dose

mg/kg

Concentration

% of

Formulation

No. of animals

Deaths Within

1 hr.

24 hr.

48 hr.

7 days

 

 

6000

50

5

5

0

0

0

0

0

0

0

0

10000

60

5

5

0

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The LD50 was considered to be >10000 mg/kg bw, when Tif. RAI rats were treated with test chemical via oral gavage route.
Executive summary:

Acute oral toxicity test was conducted using test chemical in 20 Tif. RAI rats (10 males/10 females), bred under SPF conditions at the dose concentration of 6000 and 10000 mg/kg bw. The test substance was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 50 and 60 % with carboxymethylcellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. Mortality and general symptoms was observed at 1 h, 24 h, 48 h, and 7 days.Animals were observed for clinical signs. No mortality was observed at any of the dose in treated rats. Within 2 hours after treatment the rats of both dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. The animals had recovered within 4 to 6 days.They were killed and autopsied after an observation period of 7 days. No substance related gross organ changes were seen. Hence, LD50 was considered to be >10000 mg/kg bw, when Tif. RAI rats were treated with test chemical via oral gavage route.

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